Cleared Traditional

K851469 - 76 ELW BITE CHECKER SILICONE

K851469 is an FDA 510(k) clearance for 76 ELW BITE CHECKER SILICONE, manufactured by G-C Intl. Corp.. The device is a Class 2 Dental device with product code ELW cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K851469 · G-C Intl. Corp. · Dental device
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May 1985
Decision
15d
Days
Class 2
Risk

K851469 is an FDA 510(k) clearance for the 76 ELW BITE CHECKER SILICONE. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by G-C Intl. Corp. (Scottsdale, US). The FDA issued a Cleared decision on May 1, 1985 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3660 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all G-C Intl. Corp. devices

FDA 510(k) Submission Details - K851469

510(k) Number K851469 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 1985
Decision Date May 01, 1985
Days to Decision 15 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
112d faster than avg
Panel avg: 127d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ELW Device Classification - Class 2, Special Controls

Product Code ELW Material, Impression
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3660
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - ELW Material, Impression

All 201
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K851469.
POLYJEL N.F. (NEW FORMULA)
K860146 · Dentsply Intl. · Mar 1986
PROOF ALGINATE IMPRESSION MATERIAL
K854855 · Sybron Corp. · Jan 1986
SEPTOSIL SILICONE FOR PRECISION IMPRESSION
K851388 · Specialites Septodont · May 1985
SURFLEX F
K844329 · G-C Intl. Corp. · Dec 1984
PERFOURM
K842324 · Cutter Laboratories, Inc. · Nov 1984
ODONTIC CENTRIC(BITE) REGIST. PASTE
K830044 · Wallace A. Erickson & Co. · Apr 1983